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Soybean Based Diets and CVD Risk Factors
This study has been completed.
Sponsored by: Tufts Medical Center
Information provided by: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00175097
  Purpose

To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.


Condition Intervention
Hypercholesterolemia
Behavioral: Soy protein

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Cholest-5-en-3-ol (3beta)- Lipids Proteins, soy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title: Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Fasting and non-fasting plasma lipids; end of each dietary phase
  • Fasting and non-fasting plasma lipoproteins; end of each dietary phase
  • Fasting and non-fasting plasma apolipoproteins; end of each dietary phase
  • Vascular endothelial function; end of each dietary phase
  • Susceptibility of LDL to oxidation; end of each dietary phase
  • C-reactive protein; end of each dietary phase

Secondary Outcome Measures:
  • Endogenous cholesterol synthesis; end of each dietary phase
  • Endogenous triglyceride synthesis; end of each dietary phase
  • Plasma and Urinary Isoflavone levels; end of each dietary phase
  • Genotyping of candidate genes involved in the variability observed in response to dietary modification

Estimated Enrollment: 30
Study Start Date: June 2001
Estimated Study Completion Date: May 2005
Detailed Description:

Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Plasma LDL-C >120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women.

Exclusion Criteria:

Soy allergy, Smokers, Consuming >2 alcoholic drinks per day, Pre-menopausal women.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175097

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Alice H Lichtenstein, DSc Tufts University (HNRCA)
  More Information

Study ID Numbers: HL 58008-1785, RO1 HL-58008
Study First Received: September 13, 2005
Last Updated: September 15, 2005
ClinicalTrials.gov Identifier: NCT00175097  
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
soy protein
lipids
lipoproteins
apolipoproteins
cholesterol
endothelial function

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009